Bronchial Valve Approved for Postoperative Air Leaks in Lung

An implantable bronchial valve designed to control prolonged air leaks of the lung after lobectomy, segmentectomy, or lung volume reduction surgery has been approved by the Food and Drug Administration.

The IBV Valve System includes the valve, a catheter for inserting it, and a sizing kit to measure the target area for valve implantation, according to the FDA statement announcing the approval. The system is used to treat patients “who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks [present 7 days after surgery] or significant air leaks that may become prolonged,” the FDA said.

The catheter containing the valve is passed through a bronchoscope, and the valve is then placed in the affected area of the lung, where it self-expands and redirects air flow from the diseased regions while allowing secretions and trapped air to pass through, according to Spiration Inc., the manufacturer. The valve expands and contracts with breathing and can be removed during a bronchoscopy.

The valve was approved under the Humanitarian Device Exemption program, which applies to devices for diseases or conditions that affect fewer than 4,000 people in the United States every year.

Approval was based on successful use of the valve in 58 patients with emphysema and 4 patients with prolonged air leaks, according to Spiration.

The company plans to conduct a postapproval study to obtain more safety and efficacy information about the system.

The valve is being studied in a pivotal trial of U.S. patients with severe emphysema.

Patients aged 40–70 years with predominantly upper lobe emphysema and shortness of breath with exertion who have had inadequate responses to available medical treatments and who are either ineligible for or opposed to invasive surgery are being enrolled in the trial, according to Spiration.

The study is comparing response rates and serious adverse events at 6 months among those who have the valve implanted and controls, who undergo a diagnostic bronchoscopy with no valves implanted.

The approval “is an extremely important step for patients with emphysema,” said Dr. Robert James Cerfolio, professor of surgery and chief of the section of thoracic surgery at the University of Alabama at Birmingham, who has had significant experience with these valves.

Dr. Cerfolio said in an interview that several well-designed studies have shown that “in properly selected patients, these one-way valves, which can be easily placed via a bronchoscope and which block the entry of air into emphysematous segments of the lung but allow for mucus exit, improve the breathlessness these patients experience.” These studies include several presented in May 2008 at the American Thoracic Society meeting in Toronto.

“Although the mechanism of action is different than that seen in lung volume reduction surgery, the improvement in dyspnea in these patients may be just as good,” Dr. Cerfolio noted in the interview, adding that the technique entails a 15- to 20-minute bronchoscopy, and thereby avoids the morbidity associated with surgery.

Dr. Cerfolio is an investigator in a study of the implantable bronchial valve.

An implantable bronchial valve designed to control prolonged air leaks of the lung after lobectomy, segmentectomy, or lung volume reduction surgery has been approved by the Food and Drug Administration.

The IBV Valve System includes the valve, a catheter for inserting it, and a sizing kit to measure the target area for valve implantation, according to the FDA statement announcing the approval. The system is used to treat patients “who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks [present 7 days after surgery] or significant air leaks that may become prolonged,” the FDA said.

The catheter containing the valve is passed through a bronchoscope, and the valve is then placed in the affected area of the lung, where it self-expands and redirects air flow from the diseased regions while allowing secretions and trapped air to pass through, according to Spiration Inc., the manufacturer. The valve expands and contracts with breathing and can be removed during a bronchoscopy.

The valve was approved under the Humanitarian Device Exemption program, which applies to devices for diseases or conditions that affect fewer than 4,000 people in the United States every year.

Approval was based on successful use of the valve in 58 patients with emphysema and 4 patients with prolonged air leaks, according to Spiration.

The company plans to conduct a postapproval study to obtain more safety and efficacy information about the system.

The valve is being studied in a pivotal trial of U.S. patients with severe emphysema.

Patients aged 40–70 years with predominantly upper lobe emphysema and shortness of breath with exertion who have had inadequate responses to available medical treatments and who are either ineligible for or opposed to invasive surgery are being enrolled in the trial, according to Spiration.

The study is comparing response rates and serious adverse events at 6 months among those who have the valve implanted and controls, who undergo a diagnostic bronchoscopy with no valves implanted.

The approval “is an extremely important step for patients with emphysema,” said Dr. Robert James Cerfolio, professor of surgery and chief of the section of thoracic surgery at the University of Alabama at Birmingham, who has had significant experience with these valves.

Dr. Cerfolio said in an interview that several well-designed studies have shown that “in properly selected patients, these one-way valves, which can be easily placed via a bronchoscope and which block the entry of air into emphysematous segments of the lung but allow for mucus exit, improve the breathlessness these patients experience.” These studies include several presented in May 2008 at the American Thoracic Society meeting in Toronto.

“Although the mechanism of action is different than that seen in lung volume reduction surgery, the improvement in dyspnea in these patients may be just as good,” Dr. Cerfolio noted in the interview, adding that the technique entails a 15- to 20-minute bronchoscopy, and thereby avoids the morbidity associated with surgery.

Dr. Cerfolio is an investigator in a study of the implantable bronchial valve.

An implantable bronchial valve designed to control prolonged air leaks of the lung after lobectomy, segmentectomy, or lung volume reduction surgery has been approved by the Food and Drug Administration.

The IBV Valve System includes the valve, a catheter for inserting it, and a sizing kit to measure the target area for valve implantation, according to the FDA statement announcing the approval. The system is used to treat patients “who have undergone partial or total removal of a lung lobe or lung volume reduction surgery and who experience prolonged air leaks [present 7 days after surgery] or significant air leaks that may become prolonged,” the FDA said.

The catheter containing the valve is passed through a bronchoscope, and the valve is then placed in the affected area of the lung, where it self-expands and redirects air flow from the diseased regions while allowing secretions and trapped air to pass through, according to Spiration Inc., the manufacturer. The valve expands and contracts with breathing and can be removed during a bronchoscopy.

The valve was approved under the Humanitarian Device Exemption program, which applies to devices for diseases or conditions that affect fewer than 4,000 people in the United States every year.

Approval was based on successful use of the valve in 58 patients with emphysema and 4 patients with prolonged air leaks, according to Spiration.

The company plans to conduct a postapproval study to obtain more safety and efficacy information about the system.

The valve is being studied in a pivotal trial of U.S. patients with severe emphysema.

Patients aged 40–70 years with predominantly upper lobe emphysema and shortness of breath with exertion who have had inadequate responses to available medical treatments and who are either ineligible for or opposed to invasive surgery are being enrolled in the trial, according to Spiration.

The study is comparing response rates and serious adverse events at 6 months among those who have the valve implanted and controls, who undergo a diagnostic bronchoscopy with no valves implanted.

The approval “is an extremely important step for patients with emphysema,” said Dr. Robert James Cerfolio, professor of surgery and chief of the section of thoracic surgery at the University of Alabama at Birmingham, who has had significant experience with these valves.

Dr. Cerfolio said in an interview that several well-designed studies have shown that “in properly selected patients, these one-way valves, which can be easily placed via a bronchoscope and which block the entry of air into emphysematous segments of the lung but allow for mucus exit, improve the breathlessness these patients experience.” These studies include several presented in May 2008 at the American Thoracic Society meeting in Toronto.

“Although the mechanism of action is different than that seen in lung volume reduction surgery, the improvement in dyspnea in these patients may be just as good,” Dr. Cerfolio noted in the interview, adding that the technique entails a 15- to 20-minute bronchoscopy, and thereby avoids the morbidity associated with surgery.

Dr. Cerfolio is an investigator in a study of the implantable bronchial valve.